Regulatory Success Strategies for Emerging Therapeutic Companies

​Official Registration will have to be completed on RAPS website here: https://www.raps.org/learn-develop/events/san-francisco-bay-area-chapter-in-person-event-regulatory-success-strategies-for-emerging-therapeutic-companies.html
Registration Fees & Deadlines

Member: $15.00
Student Member: $0.00
Non-Member: $25.00
Student Non-Member: $15.00 (With Promo Code)
*Please reach out to a RAPS San Francisco Chapter Leader to request a Student Promo Code.

Regulatory Success Strategies for Emerging Therapeutic Companies

Join us in person for a deep dive into winning regulatory tactics tailored for new therapeutic companies. This event is perfect if you're looking to navigate complex regulations, speed up approvals, and boost your success chances. Connect with industry pros, share stories, and walk away with practical strategies to take your company to the next level. Don’t miss out on this chance to level up your regulatory game!
Emerging therapeutic and pharmaceutical companies—whether developing innovative drugs, biologics, cell and gene therapies, digital health–integrated products, or other novel modalities—face a uniquely complex regulatory landscape. Limited resources, accelerated timelines, and evolving global expectations demand a strategic, proactive approach to regulatory planning. This panel brings together seasoned regulatory leaders, innovators, and industry strategists to explore how early‑stage companies can build the right foundations for long‑term success.

Through real‑world case studies and candid discussion, panelists will unpack the essential elements of regulatory excellence: designing smart development pathways, leveraging expedited programs, building scalable governance systems, navigating global convergence, and communicating science with clarity and credibility. Attendees will walk away with practical frameworks they can apply immediately—whether preparing for their first FDA meeting, planning pivotal studies, or scaling toward commercialization.

1. Understand how to design strategic, phase appropriate regulatory pathways
   Participants will learn to anticipate data needs, identify risks early, and align development plans with evolving global regulatory expectations—ensuring the selection of appropriate regulatory pathways and enabling smarter, more efficient decision‑making from preclinical through pivotal studies.
2. Learn how to effectively leverage expedited programs and early agency engagement
   Attendees will gain practical insight into when and how to pursue designations such as Fast Track, Breakthrough Therapy, RMAT, and PRIME, and how to prepare for high impact regulatory interactions, including first in human and pre IND/Scientific Advice meetings.
3. Acquire frameworks for building scalable governance, documentation, and communication systems
   Participants will explore real world models for establishing right sized regulatory operations, cross functional alignment, and science forward communication practices that support growth, due diligence readiness, and successful commercialization.

Event Venue

Bakar Bio Labs, 2630 Bancroft Way, Berkeley, United States

Concerts, fests, parties, meetups - all the happenings, one place.

Get App